DQY · Class II · 21 CFR 870.1250

FDA Product Code DQY: Catheter, Percutaneous

Percutaneous catheters are foundational tools in interventional cardiology and vascular medicine. FDA product code DQY covers catheters designed for percutaneous access to the vascular system.

These devices enable clinicians to navigate blood vessels to deliver therapies, measure pressures, or access cardiac structures without open surgery. They are used in angioplasty, electrophysiology, structural heart procedures, and hemodynamic monitoring.

DQY devices are Class II medical devices, regulated under 21 CFR 870.1250 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Abbott Medical, Cardiovascular Systems, Inc. and Boston Scientific Corporation.

37
Total
37
Cleared
84d
Avg days
2021
Since

List of Catheter, Percutaneous devices cleared through 510(k)

37 devices
1–24 of 37
Cleared Mar 13, 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
K260499
Abbott Medical
Cardiovascular · 28d
Cleared Dec 19, 2025
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409
Medtronic, Inc.
Cardiovascular · 80d
Cleared Dec 17, 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
K252417
Abbott Medical
Cardiovascular · 138d
Cleared Jun 17, 2025
Dorado™ PTA Balloon Dilatation Catheter
K250219
Bard Peripheral Vascular, Inc.
Cardiovascular · 144d
Cleared Jun 02, 2025
GORE® Tri-Lobe Balloon Catheter
K250410
W.L. Gore & Associates, Inc.
Cardiovascular · 109d
Cleared Apr 25, 2025
Amulet™ Steerable Delivery Sheath
K250426
Abbott Medical
Cardiovascular · 70d
Cleared Mar 27, 2025
SelectSite C304 Deflectable Catheter System (C304)
K250558
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jan 15, 2025
Ventrax™ Delivery System
K242873
Merit Medical Systems, Inc.
Cardiovascular · 114d
Cleared Dec 31, 2024
MitraClip™ G5 Steerable Guide Catheter (SGC0801)
K243224
Abbott Medical
Cardiovascular · 85d
Cleared Sep 12, 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791)
K240787
Biotronik, Inc.
Cardiovascular · 174d
Cleared Aug 26, 2024
TriClip Steerable Guide Catheter
K241538
Abbott Medical
Cardiovascular · 88d
Cleared Jun 25, 2024
ASAHI Veloute
K241158
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Feb 01, 2024
WATCHMAN TruSteer Access System (M635TU90050)
K240018
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 29, 2023
Amulet™ Steerable Delivery Sheath
K232690
Abbott Medical
Cardiovascular · 28d
Cleared Aug 30, 2023
Ventrax™ Delivery System (VTR851)
K231246
Merit Medical Systems, Inc.
Cardiovascular · 121d
Cleared Aug 22, 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
K232190
Medtronic Vascular
Cardiovascular · 29d
Cleared Aug 08, 2023
Rubicon™ Control Support Catheter (H749394323506A1)
K223633
Boston Scientific Corporation
Cardiovascular · 246d
Cleared Jun 30, 2023
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
K230156
Medtronic Vascular
Cardiovascular · 162d
Cleared Jun 02, 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
K231311
Abbott Medical
Cardiovascular · 28d
Cleared May 25, 2023
Stingray LP Catheter
K231176
Boston Scientific
Cardiovascular · 30d
Cleared Jan 10, 2023
ISAAC Neurovascular Navigation Catheter
K222115
MicroVention, Inc.
Neurology · 176d
Cleared Nov 08, 2022
SelectSite C304 Deflectable Catheter System, C315 Delivery System
K223178
Medtronic
Cardiovascular · 28d
Cleared Nov 07, 2022
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
K222873
Medtronic
Cardiovascular · 46d
Cleared Sep 12, 2022
SOFIA 88 Catheter
K214024
MicroVention, Inc.
Neurology · 264d

How to use this database

This page lists all FDA 510(k) submissions for Catheter, Percutaneous devices (product code DQY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →